Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postprandial Satiety Assessed by Visual Analogue Scales (VAS)
研究概览
简要总结
This study investigates the effects of foods enriched with alternative protein sources, including edible insects, microalgae, hemp, and legumes, on appetite regulation, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. The study is part of the CIPROMED project, which aims to support sustainable and circular food systems in the Mediterranean area.
The study consists of two phases. In the acute phase, participants will consume different protein-enriched bread products in a controlled setting following a randomized crossover design. Each participant will be exposed to multiple test conditions, allowing within-subject comparisons of postprandial responses. Outcomes assessed during this phase include satiety, hunger, food preference, craving, and short-term energy intake, measured using validated scales and dietary assessment tools.
In the chronic phase, participants will follow structured dietary interventions over a longer period within a Mediterranean dietary framework. Participants will be assigned to different dietary patterns including alternative protein-based foods and control products. This phase aims to evaluate the effects of repeated consumption of alternative protein sources on metabolic parameters, gastrointestinal tolerance, nutritional status, and behavioral responses.
The study aims to assess the acceptability and physiological effects of alternative protein sources and to compare their impact with that of traditional protein sources commonly used in Mediterranean diets.
详细描述
The acute phase of the study is designed to evaluate the short-term effects of foods enriched with alternative protein sources on appetite regulation, satiety, and eating behavior.
Healthy volunteers and individuals with overweight will participate in a controlled, within-subject crossover study conducted at the Department of Agricultural and Food Sciences (DISTAL), University of Bologna. Participants will attend five test sessions over five consecutive weeks.
During each session, participants will consume one of five test products: bread enriched with alternative protein sources (edible insect protein [Acheta domesticus], microalgae [spirulina], hemp, or legumes) or a wheat-based control bread. All products will be standardized and comparable in terms of energy content.
The order of product administration will be randomized according to a Latin square crossover design, ensuring balanced exposure to all test conditions. Randomization will be stratified by gender and weight status (normal weight/overweight).
At each test session, participants will undergo assessments of postprandial satiety, hunger, food preferences, craving responses, and short-term energy intake using validated scales and dietary assessment tools. This design allows within-subject comparisons across different protein sources while minimizing potential confounding factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Providing signed informed consent,
- •Being between 18 and 65 years of age,
- •Having a body mass index (BMI) within the normal range, defined as between 18.5 and 24.9 kg/m² or Having a body mass index (BMI) between 25.0 and 34.9 kg/m², inclusive, corresponding to the overweight category or, at most, class I obesity.
排除标准
- •Positive and documented history of allergy to legumes, insects, microalgae, shellfish, mollusks, crustaceans, snails, insect venom, house dust mites, or any component (ingredient or additive) present in the food prototypes tested, or a confirmed or suspected diagnosis of Celiac Disease.
- •History of severe allergic reactions to any type of allergen.
- •Pregnancy or Breastfeeding
研究组 & 干预措施
Control (A) to Seaweed Burger (C) Sequence
Participants follow a Mediterranean diet including control products (legume bread and/or standard fish burger) during the first intervention period, followed by a Mediterranean diet including a seaweed-based burger during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Seaweed-Based Burger (chronic phase) (Other)
Seaweed Burger (C) to Control (A) Sequence
Participants follow a Mediterranean diet including a seaweed-based burger during the first intervention period, followed by a Mediterranean diet including control products (legume bread and/or standard fish burger) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Control Products (chronic phase) (Other)
Control (A) to Insect Bread (B) Sequence
Participants follow a Mediterranean diet including control products (legume bread and/or standard fish burger) during the first intervention period, followed by a Mediterranean diet including insect protein-enriched bread (Acheta domesticus) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Control Products (chronic phase) (Other)
Control (A) to Insect Bread (B) Sequence
Participants follow a Mediterranean diet including control products (legume bread and/or standard fish burger) during the first intervention period, followed by a Mediterranean diet including insect protein-enriched bread (Acheta domesticus) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Insect Protein Bread (chronic phase) (Other)
Insect Bread (B) to Control (A) Sequence
Participants follow a Mediterranean diet including insect protein-enriched bread (Acheta domesticus) during the first intervention period, followed by a Mediterranean diet including control products (legume bread and/or standard fish burger) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Control Products (chronic phase) (Other)
Insect Bread (B) to Control (A) Sequence
Participants follow a Mediterranean diet including insect protein-enriched bread (Acheta domesticus) during the first intervention period, followed by a Mediterranean diet including control products (legume bread and/or standard fish burger) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Insect Protein Bread (chronic phase) (Other)
Control (A) to Seaweed Burger (C) Sequence
Participants follow a Mediterranean diet including control products (legume bread and/or standard fish burger) during the first intervention period, followed by a Mediterranean diet including a seaweed-based burger during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Control Products (chronic phase) (Other)
Seaweed Burger (C) to Control (A) Sequence
Participants follow a Mediterranean diet including a seaweed-based burger during the first intervention period, followed by a Mediterranean diet including control products (legume bread and/or standard fish burger) during the second period. Each period lasts approximately 2 months. Participants are assigned to one of four randomized sequences according to a Latin square crossover design.
干预措施: Mediterranean Diet with Seaweed-Based Burger (chronic phase) (Other)
结局指标
主要结局
Postprandial Satiety Assessed by Visual Analogue Scales (VAS)
时间窗: At each test session following product consumption (5-week period)
Subjective appetite sensations are assessed using a customized 100 mm Visual Analogue Scale (VAS). The scale evaluates four primary domains: hunger, fullness (satiety), desire to eat, and prospective food consumption. Participants mark a point on a 100 mm line anchored by "not at all" (0 mm) and "extremely" (100 mm). Total scores for each domain range from 0 to 100, where higher scores for satiety indicate a greater feeling of fullness, and higher scores for hunger indicate a greater urge to eat. Post-prandial ratings are measured at baseline and at specific intervals following the consumption of protein-enriched bread products.
Food Preference and Craving Responses Assessed by HTAS, LFP, and Hedonic Scale
时间窗: At each test session following product consumption (5-week period)
Food preference, motivation, and attitudes were assessed following consumption of different protein-enriched bread products using three distinct validated instruments: Health and Taste Attitude Scales (HTAS): The validated Italian version of the HTAS was used to evaluate psychological attitudes toward food. The questionnaire comprises six subscales divided into two dimensions: Health-related attitudes (General health interest, Light product interest, Natural product interest) and Taste-related attitudes (Craving for sweet foods, Pleasure orientation, Using food as a reward). 9-Point Hedonic Scale: Sensory liking of the test foods was evaluated using a 9-point scale ranging from 1 ('Extremely unpleasant') to 9 ('Extremely pleasant'). Leeds Food Preference Questionnaire (LFP): This psychometric tool was used to assess food motivation via food images. It measures two distinct components: 'Liking' (perceived pleasantness) and 'Wanting' (motivation to consume the food at testing).
Fasting Blood Glucose
时间窗: At baseline, 2 months, and 4 months
Fasting plasma glucose concentration, assessed following the dietary intervention with alternative protein sources. Unit of Measure: mg/dL
Fasting Serum Insulin
时间窗: At baseline, 2 months, and 4 months
Fasting serum insulin concentration measured following dietary interventions with alternative protein sources. Unit of Measure: µIU/mL.
Serum Triglyceride Levels
时间窗: At baseline, 2 months, and 4 months
Fasting serum triglyceride concentration measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL
Total Cholesterol Levels
时间窗: At baseline, 2 months, and 4 months
Fasting serum high-density lipoprotein (HDL) cholesterol concentration measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL
LDL Cholesterol Levels
时间窗: At baseline, 2 months, and 4 months
Fasting serum low-density lipoprotein (LDL) cholesterol concentration, calculated using the Friedewald formula, measured following dietary interventions with alternative protein sources. Unit of Measure: mg/dL
Gastrointestinal Symptoms Assessed by Nepean Dyspepsia Index (NDI)
时间窗: At baseline, 2 months, and 4 months
Gastrointestinal symptoms were assessed following dietary interventions with different protein sources using the Nepean Dyspepsia Index (NDI). This validated instrument measures symptom severity, quality of life, and the impact of functional dyspepsia on daily living. The study utilizes the version validated through translation from Australian English to Italian.
次要结局
- Incidence of Adverse Events(Within 72 hours after each test session (5-week period))
- Changes in Concomitant Medication Use(At baseline and 4 months)
- Postprandial Energy Intake and Energy Compensation Assessed by 24-Hour Dietary Recall(Within 24 hours after each test session (5-week period))
- Liver Fat Content and Hepatic Stiffness Assessed by FibroScan and Controlled Attenuation Parameter (CAP)(At baseline, 2 months, and 4 months)
- Gut Microbiota Composition(At baseline and 4 months)
- Adverse Events and Changes in Concomitant Medication Use(From baseline to 4 months)
- Appetite Sensations Assessed by Visual Analogue Scales (VAS)(At baseline, 2 months, and 4 months)
- Alanine Aminotransferase (ALT) Levels(At baseline, 2 months, and 4 months)
- Aspartate Aminotransferase (AST) Levels(At baseline, 2 months, and 4 months)
- Gamma-glutamyl Transferase (GGT) Levels(At baseline, 2 months, and 4 months)
- Fatty Liver Index (FLI)(At baseline, 2 months, and 4 months)
- Complete Blood Count (CBC)(At baseline, 2 months, and 4 months)
- Serum Creatinine and Urea(At baseline, 2 months, and 4 months)
- Urinary Renal Markers(At baseline, 2 months, and 4 months)
- C-Reactive Protein (CRP)(At baseline, 2 months, and 4 months)
- Blood Pressure(At baseline, 2 months, and 4 months)
- Serum Immunoglobulin Levels(At baseline, 2 months, and 4 months)
- Body Weight(At baseline, 2 months, and 4 months)
- Body Circumferences(At baseline, 2 months, and 4 months)
- Mood Assessed by the Beck Depression Inventory-II (BDI-II)(At baseline, 2 months, and 4 months)
- Food Neophobia Assessed by the Food Neophobia Scale (FNS)(At baseline, 2 months, and 4 months)
- Food-Related Attentional Bias Assessed by the Pictorial Dot-Probe Task(At baseline and 4 months)
研究者
Maria Letizia Petroni
Professor
University of Bologna